Suppliers / Shenzhen Hepalink Pharmaceutical Group

Shenzhen Hepalink Pharmaceutical Group

China Updated 9 July 2026

Shenzhen Hepalink Pharmaceutical Group is an API manufacturer based in China. It holds one active US drug master file. Its filings concentrate with INVIMA (CO) and MINSA (CR). Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 13 June 2025 as VAI.

1
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
2
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 13 June 2025 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Shenzhen, China Not on file
China, China 3014772595

What they file, and where

Molecule Regulators Docs
Heparin Sodium US FDA 1

Also appears on these molecule pages

Heparin API

Filings and GMP by regulator

Regulator Filings GMP certificates
INVIMA (CO) 1 None
MINSA (CR) 1 None
EMA None 5
US FDA None 1

Questions about Shenzhen Hepalink Pharmaceutical Group

Does Shenzhen Hepalink Pharmaceutical Group hold a US DMF or a CEP?
Shenzhen Hepalink Pharmaceutical Group holds 1 active US drug master file. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Shenzhen Hepalink Pharmaceutical Group FDA-registered?
One site operated by Shenzhen Hepalink Pharmaceutical Group carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Shenzhen Hepalink Pharmaceutical Group's last inspection go?
The most recent inspection on record closed on 13 June 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Shenzhen Hepalink Pharmaceutical Group manufacture?
2 registered sites are on record, in China (Shenzhen and China). Every site is listed on this page with the register it came from.
What does Shenzhen Hepalink Pharmaceutical Group make?
1 molecule is on record against Shenzhen Hepalink Pharmaceutical Group, including Heparin Sodium. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shenzhen Hepalink Pharmaceutical Group's GMP?
Current GMP certificates are on record from EMA and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 13 June 2025.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates